FDA Medical Device Recalls (openFDA)
Madison Polymeric Engineering: First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
- Recall number
- Z-1182-2018
- Recalling firm
- Madison Polymeric Engineering
- Product
- First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".
- Status
- Terminated
- Initiated
- 2017-11-03
- Posted
- not on file
- Terminated
- 2018-07-17
- Reason
- Affected lots may have exceeded its microbial limits.
- Root cause
- Process design
- Action
- Cygnus sent an Recall Letter dated November 3, 2017. Actions Required: 1. Immediately discontinue distribution of First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable). 2. Determine if any stock of the First Steps EP-4 and EP-4D with the referenced lot numbers above (as applicable) remains in your inventory. 3. Please complete the attached form and return to Cygnus Medical as indicated. It is important to notify Cygnus Medical whether or not your facility has any inventory of this product. 4. Please notify any of your customers who may have received the lots in the tables above between November 28, 2016 and January 11, 2017 with the letter provided. Once Cygnus Medical has received your completed form, if you have indicated you have any remaining product from these lots, we will issue a Return Goods Authorization, call tag, and/or FedEx/UPS account number. If you have questions regarding this matter, please contact Customer Service at 800-990-7489 or Quality Control at 203-488-4554 at x105 during business hours 8:30am-5:00pm Eastern Standard Time.
- Quantity
- 285 cases
- Distribution
- US Distribution. .
- Lot, serial or model codes
- EP-4 Lots EXP20 l 7 l 209A, EXP20 l 80512A; and EP-4D Lot EXP20 l80520A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 3001451466
- Firm city
- Branford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28